The Novel Electrolyzed Water Spray Treatment Mild Periodontitis

NCT05770258 | Completed DMC

• 1 other identifier: jia19681222
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test whether spraying the tooth of patients by use of the novel electrolyzed water spray will produce improvement in the condition of mild periodontitis.

Conditions

Periodontitis

Keywords

Electrolyzed water device; Hydroxyl radical; Tap water; Spray; Periodontitis; gingival redness; gingival swelling; gingival bleeding

Outcome Measures

Primary Outcomes (1)

• A discomfort or itching scale made by modifying the Numeric Pain Rating Scale (NPRS)

  This Score is based on descriptions of the itching that patients rate 0-10 to assess the condition of their gingival with itching. A higher score means a worse outcome. 0 means "no itching " and 10 means "the most itching".

  10 days

Secondary Outcomes (1)

• A gingival signs scale made by modifying the Numeric Pain Rating Scale (NPRS).

  10 days

Study Arms (1)

The mild periodontitis and one treatment

EXPERIMENTAL

Participants with mild periodontitis accompanied by gingival discomfort will receive one treatment with the device and complete the questionnaire.

Device: The novel electrolyzed water spray

Interventions

The novel electrolyzed water spray DEVICE

Study staff will use the novel electrolyzed water spray device and spray for approximately 5 minutes on the participant's diseased area until half a bottle (200ml) of water is used. The patients use electrolyzed water to treat the diseased area, two times a day, for 10 days. The trial consists of 10 study visits (day 1-day 10). The relief of mild periodontitis evaluation and adverse event assessments will be performed at each visit. Safety analysis will be assessed based on the reports of adverse events during the study.

The mild periodontitis and one treatment

Eligibility Criteria

• Age: 36 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mild periodontitis accompanied by gingival discomfort.
• Patient \> 18 years old.
• Systemically healthy individuals

You may not qualify if:

• severe periodontitis.
• years or older.
• Patients who take Anticoagulants or Antiplatelet Agents
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Dove Medical Press Ltd: lead

Study Sites (1)

Huinuode Biotechnology Co., Ltd.

Qingdao, China

Location

MeSH Terms

Conditions

Periodontitis; Gingival Hemorrhage

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Oral Hemorrhage; Gingival Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: An open label, single arm and before and after treatment comparison study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 15, 2023
• Study Start: January 29, 2023
• Primary Completion: July 20, 2023
• Study Completion: January 20, 2024
• Last Updated: April 25, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: until publication of this clinical study and international patent granted

Locations

CN (1)